A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis

Novan

Status and phase: Completed; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: SB414 6%; Drug: Vehicle; Drug: SB414 2%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03431610

NI-AD101

Details and patient eligibility

About

This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.

Full description

This is a phase 1b, multi-center, randomized, double-blind, vehicle-controlled study to be conducted in approximately 48 non-immunocompromised adult subjects with mild to moderate AD. Subjects will be randomized to 2 active and 1 vehicle treatment arms. Subjects will apply the study drug (SB414 or Vehicle) to affected areas twice daily for 2 weeks (14 days).

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, 18 years of age and older, and in good general health;
• EASI score >1 and ≤21, involving ≥5% body surface area (BSA).
• Two target lesions at least 5 cm2 with a TLSS ≥5. Target lesions can not be located on the groin, hands, elbows, feet, ankles, knees, face or scalp.
• Willing to not use any other products for AD during the study;
• Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit.

Exclusion criteria

• Concurrent or recent use of topical or systemic medications without a sufficient washout period;
• Immunocompromised subjects including those who are known HIV positive or receiving current immunosuppressive treatment,
• Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study;
• Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

SB414 2%

Experimental group

Description:

SB414 2% topically twice daily

Treatment:

Drug: SB414 2%

SB414 6%

Experimental group

Description:

SB414 6% topically twice daily

Treatment:

Drug: SB414 6%

Vehicle Cream

Placebo Comparator group

Description:

Vehicle Cream topically twice daily

Treatment:

Drug: Vehicle